Psychological Distress in Patients With COPD

NCT ID: NCT06395311

Last Updated: 2024-12-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 98 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-13
• Study Completion Date: 2024-12-01

Brief Summary

Chronic obstructive pulmonary disease (COPD) can significantly impact a person's quality of life, not only physically but also mentally. This cross-sectional study aims to assess the psychological well-being of COPD patients by utilising specific questionnaires. These questionnaires will evaluate various aspects of mental health, including anxiety, depression, and potentially other relevant factors like self-compassion or fear of negative evaluation, self-efficacy, shame, and guilt. Additionally, the study will examine how these psychological factors relate to the severity of COPD symptoms, such as dyspnea and functional limitations. By understanding the psychological impact of COPD, this research hopes to emphasize the importance of medical education and mental health support in COPD management strategies.

Detailed Description

Chronic obstructive pulmonary disease (COPD) profoundly impacts both physical health and quality of life. Beyond the challenges of breathlessness and functional limitations, COPD patients often struggle with anxiety, depression, and other mental health difficulties at a much higher rate than the general population. This cross-sectional study seeks to understand the current state of psychological well-being in patients with COPD and explore how it relates to the severity of their condition. the study aims to assess the psychological well-being of COPD patients by utilizing specific questionnaires. These questionnaires will evaluate various aspects of mental health, including anxiety, depression, and potentially other relevant factors like self-compassion or fear of negative evaluation, self-efficacy, shame, and guilt. Additionally, the study will examine how these psychological factors relate to the severity of COPD symptoms, such as dyspnea and functional limitations. Investigators will use the following tests:

1. The Hospital Anxiety and Depression Scale (HADS) to identify and measure the severity of anxiety and depression symptoms.

2. The COPD Assessment Test (CAT) to measure the impact of COPD on a person's well-being.

3. The State Shame and Guilt Scale (SSGS) to measure a person's shame and guilt.

4. The Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) to measure the patient's self-efficacy in managing their chronic respiratory disease.

5. The Brief Fear of Negative Evaluation Scale (BFNE) to assess an individual's anxiety around being judged or criticized by others.

6. The Self-Compassion Scale Short Form (SCS-SF) to measure key components of self-compassion.

7. The mMRC scale to evaluate the patient's level of breathlessness (dyspnea) in everyday life.

8. The six-minute walking test (6MWT) to measure how far a person can walk on a flat, hard surface in six minutes.

Conditions

COPD; Quality of Life; Mental Health; Psychological Distress

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

COPD subjects

Diagnosis of COPD established by a qualified healthcare professional (e.g., pulmonologist, general practitioner) based on:

Post-bronchodilator spirometry demonstrating airflow obstruction (FEV1/FVC < 0.70) following GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines.

Age: 18 years or older. Adequate visual and/or auditory abilities to read and understand study materials/questionnaires or receive instructions verbally

COPD psychological well-being assessment

Intervention Type: OTHER

Patients will complete the following questionnaires: Hospital Anxiety and Depression Scale (HADS), COPD Assessment Test (CAT), State Shame and Guilt Scale (SSGS), Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE), Brief Fear of Negative Evaluation Scale (BFNE), Self-Compassion Scale Short Form (SCS-SF). Dyspnea will be evaluated with the mMRC scale, and functional capacity will be assessed with the six-minute walking test (6MWT).

Interventions

COPD psychological well-being assessment

Patients will complete the following questionnaires: Hospital Anxiety and Depression Scale (HADS), COPD Assessment Test (CAT), State Shame and Guilt Scale (SSGS), Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE), Brief Fear of Negative Evaluation Scale (BFNE), Self-Compassion Scale Short Form (SCS-SF). Dyspnea will be evaluated with the mMRC scale, and functional capacity will be assessed with the six-minute walking test (6MWT).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of COPD established by a qualified healthcare professional (e.g., pulmonologist, general practitioner) based on:
• Post-bronchodilator spirometry demonstrating airflow obstruction (FEV1/FVC < 0.70) following GOLD (Global Initiative for Chronic Obstructive Lung Disease) guidelines.
• Age: 40 years or older.
• Adequate visual and/or auditory abilities to read and understand study materials and questionnaires or receive instructions verbally if needed.

Exclusion Criteria

• Other major respiratory illnesses: diagnosis of severe asthma, cystic fibrosis, lung cancer, or other significant respiratory diseases that could present with distinct psychological profiles.
• Acute COPD exacerbation: experiencing an acute exacerbation of COPD symptoms within the past four weeks.
• Unstable comorbid conditions: the presence of severe, uncontrolled medical conditions that could significantly affect cognitive function, well-being, or the ability to participate (e.g., unstable heart failure, end-stage renal disease, rapidly progressing malignancy).
• Severe mental disorders: current or recent diagnosis of a major psychiatric disorder that could significantly interfere with the interpretation of psychological measures or the ability to provide reliable responses (e.g., active schizophrenia, bipolar disorder, a major depressive episode).
• Problematic substance abuse: current problematic alcohol or illicit drug use (including opioids).
• Inability to provide informed consent: individuals lacking the cognitive capacity to understand the study and provide consent.
• Limited language proficiency: insufficient understanding of the language in which the study materials, including questionnaires, are administered.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara

OTHER_GOV

Sponsor Role: lead

Responsible Party

Crisan Alexandru Florian

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandru Crișan, PhD

Role: PRINCIPAL_INVESTIGATOR

Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara

Locations

Spitalul de Boli Infectioase si Pneumoftiziologie Victor Babes

Timișoara, Timiș County, Romania

Countries

Romania

Other Identifiers

2045/11.03.2024

Identifier Type: -

Identifier Source: org_study_id